Covaxin: USFDA delays approval while seeking additional data

G Naga Sridhar Hyderabad | Updated on June 11, 2021

Asks Bharat Biotech's US partner to seek full licence instead of EUA

The US Food and Drug Administration (USFDA) has asked Ocugen, Bharat Biotech’s partner in the US, to apply for a full licence for its Covid-19 vaccine, Covaxin, instead of seeking Emergency Use Authorisation (EUA). The US regulator had also sought additional data and information on Covaxin.

The recommendation from the USFDA came in response to a EUA sought by Hyderabad-based Bhart Biotech’s US partner for Covaxin, Ocugen Inc.

Full approval

According to Ocugen, it would now work towards obtaining a full approval for Covaxin in the US as per the USFDA norms. It expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin, as per a regulatory filing.

Bharat Biotech has already announced that complete data on Phase 3 trials will be out in July and phase 4 trials will also be conducted.

“While this will extend our timelines, we are committed to bringing Covaxin to the U.S.,” Ocugen Chief Executive Officer Dr Shankar Musunuri said.

Also read: Covaxin stock for 45-plus age group almost over: AAP MLA

When contacted , Bharat Biotech said the USFDA had earlier communicated that no new EUAs will be approved for Covid vaccines. With good herd immunity and significant percentage of the population vaccinated, the pandemic is declining in the United States, it said

“All applications have to follow the biological license application process, which is the standard process for vaccines. Data from an additional clinical trial will be required to support the marketing application submission for Covaxin,’’ it added.

Covaxin has received EUAs from 15 countries with more than 50 countries in process.

Published on June 11, 2021

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